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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00750282




Registration number
NCT00750282
Ethics application status
Date submitted
9/09/2008
Date registered
10/09/2008
Date last updated
24/07/2014

Titles & IDs
Public title
Phase II Study of Florbetaben (BAY 94-9172) PET Imaging for Detection/Exclusion of Cerebral ß-amyloid in Patients With Probable Alzheimer's Disease Compared to Healthy Volunteers
Scientific title
An Open-label, Non-randomized, Multi-center Study to Optimize Image Assessment and Evaluate the Efficacy and Safety of BAY 94-9172 (ZK 6013443) Positron Emission Tomography (PET) for Detection/Exclusion of Cerebral Amyloid Beta in Patients With Probable Alzheimer's Disease Compared to Healthy Volunteers
Secondary ID [1] 0 0
2007-002256-42
Secondary ID [2] 0 0
311741
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer Disease 0 0
Amyloid Beta-Protein 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias
Metabolic and Endocrine 0 0 0 0
Metabolic disorders
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Florbetaben (BAY94-9172)

Experimental: Florbetaben (BAY94-9172) -


Treatment: Drugs: Florbetaben (BAY94-9172)
Healthy volunteers and patients with probable Alzheimer's disease receiving single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Specificity and Sensitivity of Florbetaben PET Scans Obtained in Part A Using Two Separate Algorithms and the Onsite Clinical Diagnosis as the Standard of Truth
Timepoint [1] 0 0
90 - 110 min after investigational medical product (IMP) injection
Primary outcome [2] 0 0
Specificity and Sensitivity of Florbetaben PET Scans Obtained in Part B Using Two Separate Algorithms and the Onsite Clinical Diagnosis as the Standard of Truth.
Timepoint [2] 0 0
90 - 110 min after IMP injection
Secondary outcome [1] 0 0
Sensitivity and Specificity for All Participants Using Two Additional Imaging Windows for the Visual Assessment
Timepoint [1] 0 0
45 - 60 min and 110 - 130 min after IMP injection
Secondary outcome [2] 0 0
Kappa Coefficient as a Measure of Agreement Between Readers Concerning the Visual Assessment of Abnormality of the Brain Scan (Based on BAPL Score)
Timepoint [2] 0 0
45-60 min, 90-110 min, 110-130 min
Secondary outcome [3] 0 0
Standard Uptake Value Ratios for Florbetaben Signal
Timepoint [3] 0 0
90-110 min post injection

Eligibility
Key inclusion criteria
* Each subject / Healthy volunteer (HV) who meets the following criteria will be eligible for enrollment into the study:

* Is a man or woman and is > 55 of age, whereby females must be without childbearing potential (confirmed by either: age >/= 60; or history of hysterectomy, or last spontaneous bleeding at least 2 years prior to the study start)
* Has at least 6 years of education
* Is able to provide informed consent, understand the information provided on the purpose and conduct of the trial and to comply with study procedures
* Possesses a general health that permits adequate compliance with all study procedures
* The subject, or the subject and caregiver (for probable AD patients) will be compliant and have a high probability of completing the study
* Informed consent has been signed and dated (with time) by the subject and/or the subject's caregiver (for probable AD patients)
* Inclusion criteria for HV only:

* Has no evidence of cognitive impairment
* Has MRI brain scan that has been judged as "normal" (age- appropriate)
* Inclusion criteria for patients with AD only:

* Presents with positive assessment for dementia of Alzheimer's type
* Does not fulfill the criteria Dementia with Lewy Bodies (DLB) or Vascular Dementia (VaD)
* MRI brain scan findings that do not reveal changes indicative of stroke and/or generalized cerebrovascular disease
* Has a caregiver that is willing and able to attend all study visits and perform the psychometric tests requiring the presence of a caregiver
Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Has any contraindication to MRI examination scan
* Is scheduled for surgery and/or another invasive procedure within the time period of up to 24 hours following IMP application
* Is allergic to the IMP or any of its constituents and/or has a history of severe allergic reactions to drugs or allergens (e.g. patients / volunteers with allergic asthma)
* is critically ill and/or medically unstable and whose clinical course during the observation period is unpredictable
* Has a history of exposure to any radiation >15 milli Sieverts (mSv)/year (e.g. occupational or radiation therapy)
* Is receiving drug therapy or other treatment that is known to lead to greatly fluctuating values of the hematological or chemical laboratory parameters or to severe side effects (e.g. chemotherapy)
* Has been previously enrolled in this study or participated in a clinical study involving an investigational pharmaceutical product within 30 days prior to screening, and/or any radiopharmaceutical
* Has a brain tumor or other intracranial lesion, a disturbance of cerebro-spinal fluid (CSF) circulation (e.g., normal pressure hydrocephalus) and/or a history of head trauma or brain surgery
* Has an inflammatory or infectious central nervous system (CNS) disease, e.g. multiple sclerosis, HIV, syphilis, or Creutzfeldt-Jacob disease
* Has a history, physical, laboratory or imaging findings indicative of a neurological or psychiatric illness
* Has another disease that can cause disturbance of brain function (e.g. vitamin B12 or folic acid deficiency, disturbed thyroid function)
* Has a history of alcohol or drug abuse
* Has history of severe persistent depression

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2010
Sample size
Target
Accrual to date
Final
422
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
- Westmead
Recruitment hospital [2] 0 0
- Adelaide
Recruitment hospital [3] 0 0
- Heidelberg
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
3084 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
Rhode Island
Country [6] 0 0
Germany
State/province [6] 0 0
Bayern
Country [7] 0 0
Germany
State/province [7] 0 0
Nordrhein-Westfalen
Country [8] 0 0
Germany
State/province [8] 0 0
Sachsen
Country [9] 0 0
Germany
State/province [9] 0 0
Berlin
Country [10] 0 0
Japan
State/province [10] 0 0
Hyogo
Country [11] 0 0
Japan
State/province [11] 0 0
Tokyo
Country [12] 0 0
Switzerland
State/province [12] 0 0
Zürich

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Life Molecular Imaging SA
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bayer Study Director
Address 0 0
Bayer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Barthel H, Gertz HJ, Dresel S, Peters O, Bartenste... [More Details]

Results are available at https://clinicaltrials.gov/study/NCT00750282